Researchers and institutions are ethically and legally obligated to safeguard research participants'privacy and the confidentiality of their data. Indeed, the success of the research enterprise depends on the public's confidence that private information will be vigorously protected. Certificates of Confidentiality, authorized by federal law, are an important tool for meeting this expectation. By shielding researchers and institutions from forced disclosure of identifying data in any legal proceeding, Certificates are intended to facilitate participation by reassuring prospective participants about the security of their information and thus allow research to proceed on sensitive topics critical to the public's health. In fact, Certificates are commonly believed to offer near absolute privacy protection. Their use has recently been promoted in the context of burgeoning efforts to build large-scale research platforms and new requirements for an unprecedented degree of data sharing. There is, however, a remarkable paucity of evidence upon which to base conclusions about the strength of the protection Certificates afford. A recent case that reached the North Carolina Court of Appeals suggests that the full legal effect of a Certificate is unclear. Empirical data are needed concerning when, why, and how Certificates are used, including stakeholders'understanding of the protection they provide and how that affects their assessment of research risk. The perceptions of Institutional stakeholders, including IRB chairs and institutional legal counsel, are particularly important given the central role they play in developing and implementing policies and practices for recommending or requiring that a Certificate be obtained. The purpose of this study is to examine how research institutions understand and use Certificates in protecting research participants and the role they play in assessments of risk. Specifically, the aims are to: Assess IRBs'use and understanding of Certificates and the role of Certificates in risk assessments Explore institutional legal counsel perceptions of the protections Certificates provide and their institution's experiences with legal demands for identifiable research data Analyze the legal foundations for Certificates and comparable confidentiality protections We will form a multidisciplinary Advisory Panel to provide expert guidance throughout the life of our study. At the conclusion of our research, we will hold an in-person meeting with the Panel to review our findings;identify policy priorities that could strengthen the protection Certificates afford, enhance stakeholders'understanding of Certificates, and promote the appropriate use of Certificates;and elucidate additional research needed to optimize the role of Certificates in protecting research participants. PUBLIC HEALTH RELEVANCE: Certificates of Confidentiality are an important tool for meeting researchers'and institutions'ethical and legal obligations to safeguard research participants'privacy and the confidentiality of their data. There is, however, a remarkable paucity of evidence upon which to base conclusions about the strength of the protection Certificates afford. The results of our study will provide empirical data concerning when, why, and how Certificates are used, including institutional stakeholders'understanding of the protection they provide and how that affects their assessment of research risk. These data will help identify immediate policy priorities that could enhance all stakeholders'understanding of Certificates and promote the appropriate use of Certificates. They will also provide a foundation for future research to aid longer term policy development that optimizes the role of Certificates in protecting research participants.